FDA Adverse Event
Death
Summary report: N
00110203000
MDR report key: 96890
·
Received June 5, 1997
Report
- Report Number
- 1822565-1997-00067
- Event Type
- Death
- Date Received
- June 5, 1997
- Date of Event
- March 22, 1997
- Report Date
- June 4, 1997
- Manufacturer
- ZIMMER, INC.
- Product Code
- LOD
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING INSERTION OF BONE CEMENT PT EXPIRED. STAFF ORTHOPAEDIC SURGEON AND MEDICAL CORONER DO NOT FEEL THE INCIDENT WAS CEMENT RELATED. THE PT DIED FROM COMPLICATIONS RELATED TO THE PROCEDURE (MDR97-00067).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 00110203000 Implant | Z BN CM LVC ROP 80/40 KIT | LOD | ZIMMER, INC. | 3900 | 74157700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death |